US8457371B2 - Method and apparatus for mapping a structure - Google Patents

Abstract

An area of a patient can be mapped with a system operable to identify a plurality of locations and save a plurality of locations of a mapping instrument. The mapping instrument can include one or more electrodes that can sense a voltage that can be correlated to a three dimensional location of the electrode at the time of the sensing or measurement. Therefore, a map of an area or volume can be determined based upon the sensing of the plurality of points without the use of an imaging device. An implantable medical device can then be navigated relative to the mapping data.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims benefit of pending U.S. Provisional Application No. 61/046,298, filed Apr. 18, 2008, entitled “Method and Apparatus for Mapping A Structure.” U.S. patent application Ser. No. 12/117,537 is concurrently filed with this application. The disclosures of all of the above identified applications are incorporated herein by reference.

FIELD

The present disclosure relates generally to electrode position identification, and particularly to mapping an anatomical region and illustrating electrode positions relative to the map.

BACKGROUND

The statements in this section merely provide background information related to the present disclosure and may not constitute prior art.

The human anatomy includes many types of tissue that can either voluntarily or involuntarily, perform certain functions. After disease or injury, or due to certain genetic predispositions certain tissues may no longer operate within general anatomical norms. For example, after disease, injury, time, or combinations thereof, the heart muscle may begin to experience certain failures or deficiencies. These failures or deficiencies may be corrected or treated with implantable medical devices (IMDs), such as implantable pacemakers, implantable cardioverter defibrillator (ICD) devices, cardiac resynchronization therapy defibrillator devices, or combinations thereof.

One of the main portions of the IMD can include a lead that is directly connected to tissue to be affected or treated by the IMD. The lead can include a tip or electrode portion that is directly connected to a first portion of the anatomical tissue, such as a muscle bundle, and a lead body that connects to the second main portion, which is the device body or therapeutic driving device. It is generally known that the device body or case portion can be implanted in a selected portion of the anatomical structure, such as in a chest or abdomen, and the lead can be inserted through various venous portions so that the tip portion can be positioned at the selected position near or in the heart muscle.

The IMDs are implantable devices that may require the use of imaging devices for implantation. The imaging devices can include fluoroscopes that expose a patient and a surgeon to ionizing radiation. In addition, the use of the imaging device can require time for acquiring image data and understanding the images from the image data. For example, considerable experience and training may be required for proper interpretation of fluoroscopic images.

The use of imaging devices can require various additional costs and procedures. For example, fluoroscope devices employ ionizing radiation to acquire images of a patient. Individuals, such as surgeons and technicians that are constantly or repeatedly exposed to the ionizing radiation generally wear protective clothing. The protective clothing, however, can be heavy and may strain operators and staff. In addition, the imaging devices, such as fluoroscopes, can be relatively expensive and require extensive training in the use of the imaging device. Due to cost and training requirements, therefore, certain facilities may forego acquiring the imaging devices thereby reducing the number of facilities able to perform certain procedures.

SUMMARY

A position sensing unit (PSU) system is operable to map and illustrate mapped and saved points. The system can determine the location of an electrode by generating a voltage in a patient and calculating a impedance at the electrode. The calculated impedance is used to determine the position of the electrode as in a patient or other appropriate conducting medium.

The saved points may be used to create a map determined with the electrode that can be used to determine a location of a later positioned electrode. The electrode positioned in the anatomy can include a pacing lead or other purpose. The electrode can generally be a part of an IMD. The map generated with the PSU can be used to guide or navigate a lead to a selected location without external imaging devices.

The use of the position sensing unit to generate a map can eliminate or reduce the need for an imaging device. The imaging devices, such as fluoroscopes, as discussed above, can require additional costs and training requirements that may be eliminated. For example, if a fluoroscope is not used protective clothing, such as a lead apron, may not be required to be worn by individuals in a room and can reduce strain and weight carried by the individuals. In addition, elimination of ionizing radiation doses can assist a patient and a user. Further, in the use of the position sensing unit and the elimination or reduction in use of an imaging device, a cost center or capital investment may not be required while allowing a facility to perform selected procedures, as discussed herein.

Further areas of applicability will become apparent from the description provided herein. It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.

DRAWINGS

The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way.

FIG. 1 is an environmental view of a mapping or navigation system;

FIG. 2 is a detailed view of a position sensing unit, according to various embodiments;

FIG. 3 is a detailed view of a mapping catheter according to various embodiments;

FIG. 4 is a detailed view of a retractable electrode lead and an associated sheath or catheter, according to various embodiments;

FIG. 4A is a detailed view of a retractable electrode lead and an associated sheath or catheter in a retracted configuration, according to various embodiments;

FIG. 4B is a detailed view of a retractable electrode lead and an associated sheath or catheter in an extended configuration, according to various embodiments;

FIG. 5 is a view of a patient with a mapping catheter inserted into an internal organ of the patient;

FIG. 6 is a detailed view of a display device with mapping data illustrated thereon;

FIG. 7 is a flow chart illustrating a method of mapping with a position sensing unit;

FIG. 8 is a detailed environmental view of a mapping catheter and a display device displaying related mapping information;

FIG. 9 is a flow chart illustrating a method of rendering a surface based on mapping information, according to various embodiments;

FIG. 10 is a display device illustrating raw mapping information and surface rendered data;

FIG. 11 is a flow chart illustrating a method of rendering a surface based on mapping information, according to various embodiments;

FIG. 12 is a display device illustrating surface rendered data; and

FIG. 13 is a view of an implantable medical device positioned within a patient.

DETAILED DESCRIPTION

The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses. The devices described herein include an exemplary number of leads, case bodies, etc. One will understand that the components, including number and kind, may be varied without altering the scope of the disclosure. Also, devices according to various embodiments may be used in any appropriate diagnostic or treatment procedure, including a cardiac, neural, or other anatomical procedures.

With reference toFIG. 1, a navigation ormapping system20 is illustrated. Thenavigation system20 can be operated by auser22 with aninstrument24 to map a selected space, such as a portion of apatient26. Theinstrument24 can also be navigated relative to thepatient26. Theinstrument24 can be moved relative to thepatient26 for various procedures, including lead placement relative to the heart, mapping of the heart, mapping of a selected organ of thepatient26, or guiding or navigating theinstrument24 relative to any appropriate portion of thepatient26.

Thenavigation system20 can include various components, such as anoptional imaging device28. Theoptional imaging device28 can include a fluoroscope, such as a fluoroscope configured as a C-arm. The C-arm fluoroscope can include animaging section30 and ax-ray emitting section32. Theimaging device28 can be controlled by acontroller34. Images acquired with theimaging device28 can be displayed on adisplay device35 that is associated with theimaging device28. It will be understood, however, that theseparate display device35 is not required. In addition, if the imaging device is an x-ray imaging device any radio-opaque portions will appear as a part of the image when viewed, including theinstrument24.

Thecontroller34 can control theimaging device28 and can store images generated with theimaging device28 or transmit data or receive instructions via adata transmission line36 to or from a processor and/or memory, such as one that may be included in aworkstation38. While theoptional imaging device28 illustrated here is a fluoroscopic c-arm other imaging devices, such as CT, MRI, ultrasound, etc., can also be employed. Moreover, it will be understood that thecommunication line36 can be any appropriate communication line such as a wired communication line, a wireless communication system, or any other data transfer mechanism.

Thenavigation system20 can further include a Position Sensing Unit (PSU)40 as illustrated inFIG. 2. ThePSU40 can include a impedance or Electrical Potential (EP)system40. The PSU can be the LocaLisa® Intracardiac Navigation System as previously provided by Medtronic, Inc. of Minneapolis, Minn., USA. ThePSU40 can include a control or drivingunit42 that includes one or more input oroutput connectors44 to interconnect with a plurality of current conducting or drive patches connected directly with thepatient26. The current patches can include patches to create three substantially orthogonal voltage or current axes within thepatient26. For example, a first y-axis patch46aand a second y-axis patch46bcan be interconnected with the patient26 to form a y-axis (such as an axis that is generally superior-inferior of a patient) with a conductive path such that the conducted current establishes a voltage potential gradient substantially along this axis and between thepatches46aand46b. A related y-axis current flows from the first y-axis patch46ato the second y-axis patch46bsubstantially along the y-axis. Likewise, afirst x-axis patch48aand asecond x-axis patch48bcan be connected with the patient26 to create a x-axis (such as an axis that is generally medial-lateral of a patient) with a voltage gradient substantially along the x-axis between thepatches48aand48dand a corresponding x-axis current. Finally, a first z-axis patch50aand a second z-axis patch50bcan be connected with a patient26 to create a z-axis (such as an axis that is generally anterior-posterior of a patient) with a voltage potential gradient substantially along the z-axis between thepatches50aand50bwith a corresponding z-axis current. The three axes are generally formed to have an organ or area of interest that the common intersection or origin of each of the axes x, y, z. Accordingly, the patches46-50 can be positioned on the patient26 to achieve the selected placement of the axes x, y, z relative to thepatient26. Each of the patches46a-50bcan be interconnected with the PSU input/output (I/O)box42, via a wire connection or other appropriate connection at theports44.

The current applied between the related patches generate a small current, (about 1 microampere to about 100 milliamperes), in the patient along the axis between the respective patch pairs. The induced current can be of a different frequency for each of the related patch pairs to allow for distinguishing which axis is being measured. The current induced in thepatient26 will generate a voltage gradient across different portions, such as the heart, that can be measured with an electrode, as discussed in further detail herein. The sensed voltage can be used to identify a position along an axis (whereby each axis can be identified by the particular frequency of the current being measured) to generally determine a position of electrode along each of the three axes. Although a voltage can be sensed, an impedance can also be calculated or measured to determine a location in a similar manner. It will be understood, that a sensing of voltage will not eliminate other possible measurements for position determination, unless specifically indicated. As discussed further herein, the position of the electrode with respect to each of the three axes can be used as map data to be illustrated on thedisplay device58. Electrodes within the patient and reference electrodes are interconnected with the PSU I/O box42 such that the signals are processed by high impedance circuitry so as to not load and distort the sensed signals.

In addition, reference patches can be interconnected with thepatient26 for reference of guiding or mapping with theinstrument24 relative to thepatient26. The reference patches can include afirst reference patch52aand asecond reference patch52b. The placement of thereference patches52a,52bcan be any appropriate position on thepatient26, including those discussed further herein according to various embodiments. For example, thefirst reference patch52acan be positioned substantially over the xiphoid process on the skin of the patient26 directly exterior to the xiphoid process of thepatient26. Thesecond reference patch52bcan be positioned substantially directly across from thefirst patch52aon a dorsal surface of thepatient26. By positioning thereference patch52aat this location, the reference patch has relatively little motion with respect to the heart. By positioning thereference patches52a,bat these locations, respiration may be monitored by measuring the relative voltage or impedance difference between the two reference electrodes using thePSU40.

The PSU I/O box42 can be interconnected with theworkstation38, via a connection ordata transfer system56. Thedata transfer system56 can include a wire transmission, wireless transmission, or any appropriate transmission. Theworkstation38 can receive signals, which can be analog or digital signals, regarding voltages sensed by thereference patches52a,52band electrodes on theinstrument24. The signals can be used to determine a relative location of theinstrument24 and to display the determined relative location on thedisplay device58. Thedisplay device58 can be integral with or separate from theworkstation38. In addition, various interconnected or cooperating processors and/or memory can be provided to process various information, each may be a part of theworkstation38 or separate therefrom. The processors can process the signals from the patches46-52 andinstrument24 to determine the position of theinstrument24, display the determined positions or other data on thedisplay device58.

Thenavigation system20 can further include user input or data input devices such as akeyboard60, ajoystick62, or afoot pedal64. Each of the input devices,60-64 can be interconnected with theworkstation38 or appropriate systems for inputting information or data into theworkstation38. This information or data can include identifying appropriate information, as discussed further herein, such as various components, or anatomic regions.

With continuing reference toFIGS. 1 and 2, with particular reference toFIG. 2, the multiple driving or voltage patches46a-50bare used to conduct current in the patient to create voltage potentials within thepatient26 that can be sensed by electrodes that are positioned on or within thepatient26. It will be understood that the driving patches46-50 can be positioned on the patient26 at any appropriate locations, such as the locations described with the Local Lisa™ position sensing unit previously provided by Medtronic, Inc. of Minneapolis, Minn., USA. The PSU I/O box42, can create voltages and generate a small current along the axes between the related patches. The current generated can include different frequencies along the different x, y, and z axes to distinguish the x, y, and z-axes.

Theinstrument24 can include an electrode, as discussed further herein, which is able to sense the voltage generated within thepatient26 due to the patches46a-50bpositioned on thepatient26. The sensed voltage can be used to calculate a impedance of the tissue in the patient26 based upon the voltage potential gradient generated between the respective pairs of patches and the corresponding current. Generally, the current is carried due to an electrolyte in thepatient26, such as blood, interstitial fluid, etc. within aheart80 and body of thepatient26.

As discussed further here, the calculated impedance or sensed voltage can be used to determine a location of the electrode of theinstrument24 relative to a selected reference, such asreference patch52aor52b. Thereference patches52a,52bcan be positioned at any appropriate position on thepatient26. As discussed above, thefirst reference patch52acan be positioned substantially over the xiphoid process of thepatient26. The positioning of thefirst reference patch52aover the xiphoid process of the patient26 can again allow for minimal movement of thereference patch52adue to respiration or cardiac movement. Thereference patches52a,52bcan also be used for repeat or multiple procedures at different times. For example, the reference patches can be used to reorient or register themapping data194 to the patient26 at a second time. Therefore, thereference patch52acan be a substantially fixed reference patch for reference regarding the voltage generated by thePSU40.

Thesecond reference patch52bcan be positioned substantially directly across the thickness of the patient26 on a dorsal side of the patient26 from thefirst reference patch52b. The tworeference patches52a,52bcan be on the same horizontal plane. The horizontal plane is perpendicular to the coronal or median planes of an anatomy. Thesecond reference patch52bcan also be substantially fixed relative to thepatient26, at least in part because it is positioned on the dorsal side of thepatient26. In addition, thesecond reference patch52bcan be used to reorient the data acquired with the electrodes of theinstrument24 if thefirst reference patch52ais removed. For example, during a procedure, an emergency may require the removal of all of the patches from a ventral side of thepatient26, including thefirst reference patch52a. After the treatment of the emergency, however, the data acquired with theinstrument24 can be reoriented relative to the patient26 or relative to theinstrument24 using thesecond reference patch52b. Accordingly, use of at least tworeference patches52a,52bcan assist to reference or realign the mapping data acquired relative to thepatient26.

With reference toFIG. 3, according to various embodiments, a mapping ornavigation catheter100 can be used as theinstrument24. Themapping catheter100 can include various portions, such as a balloon orinflatable portion102. The inflatable orexpandable portion102 can be part of a catheter system, such as a Swan-Ganz Balloon Catheter System sold by Edwards Lifesciences REF: D97120F5 (5F)] and generally known in the art.

Themapping catheter100 can further include asheath104, which can be deflectable. A lead or catheter defining alumen106 can extend through thesheath104 and through theballoon102. A tip orfirst electrode108 can be provided on a distal end of thecatheter106 and a ring orsecond electrode110 can be provided on a proximal end of theballoon portion102. This can provide at least two electrodes to sense a voltage within thepatient26 when themapping catheter100 is positioned within the patient and the current patches are being driven. As discussed further herein, theelectrodes108,110 can sense a voltage produced within thepatient26 and from the sensed voltage an impedance can be calculated to determine a location of themapping catheter100, as discussed further herein.

In addition, during mapping, theballoon portion102 can assist in assuring that thecatheter106 does not puncture or perforate a wall of theheart80 or other blood vessel. Theballoon portion102 can also act as a stop when themapping catheter100 is being moved through theheart80 or other anatomical portion. Theballoon portion102 can be inflated or deflated as selected by theuser22. Inflation of theballoon portion102 can be performed in any appropriate manner such as directing a fluid, such as a liquid or gas, through thecatheter106. In addition, themapping catheter100 can be moved relative to the patient26 in any appropriate manner, such as a steering mechanism (not particularly illustrated) or via anatomical forces placed upon various portions of thecatheter100, such as a drag created on theballoon portion102 by the flow of blood. Further, various conductors can be used to transfer the sensed voltage from theelectrodes108,110 to the PSU I/O box42.

With reference toFIG. 4, alead120 is illustrated that can also be used as theinstrument24. Thelead120 can be any appropriate lead such as the model 5076 sold by Medtronic Inc. of Minneapolis, Minn., USA. Thelead120 can be used as part of an implantable medical device300 (illustrated inFIG. 13), but may not generally be used to acquiring mapping data. The position of thelead120, however, can be determined and displayed on thedisplay device58, as discussed further herein. Thelead120 can include an external sheath or covering122 that substantially insulates an interior of the lead120 from an external environment, such as an anatomical portion. Thelead120 can include aconductor124 and aretractable helix electrode126. Theelectrode126 can be used with thePSU40 to determine the location of theelectrode126. However, generally during insertion and placement of thelead120, theelectrode126 is substantially retracted into the covering122 of thelead120. Accordingly, an appropriate or strong signal of the voltage may not be efficiently determined in the retracted state. Therefore, an opening, which can include one or more portals orwindows128a,128bcan be formed in the covering122 to allow an electrolyte to contact theelectrode126 while moving theelectrode126 through thepatient26. A voltage can be efficiently sensed by the exposedelectrode126 through thewindow portions128a,128b.

As discussed herein, the determined position of thelead120 can be illustrated on a display device relative to data collected either with thelead120 or with themapping catheter100. Accordingly, the sensed voltage through the window128 can be used to determine a position of thelead120 relative to the mapping data. It will also be understood, thelead120 may include more than theimplantable electrode126. Thelead120 may include at least a second electrode, such as aring electrode127. A voltage can also be sensed by thering electrode127 and also be used for determining a position of thelead120 or a portion thereof.

With reference toFIGS. 4A and 4B, alead140, according to various embodiments, can include a moveablewindow covering portion142. Thecover142 can move with theelectrode126 as theelectrode126 is moved out of the coveringsheath122. As illustrated inFIG. 4A, when in the retracted configuration thewindows128a,128bare uncovered to allow an electrolyte to contact theelectrode126 over a large surface area which lowers impedance of the circuit. As illustrated inFIG. 4B, when in the extended configuration thewindows128a,128bare covered by the window covering142 which blocks access to theelectrode126 though thewidows128a,128b.

Accordingly, thecover142 can move from a non-covering or opened position to a covering position relative to the window128 when theelectrode126 is deployed or extended. Thecover142 can cover the window128 to ensure that a material, such as blood or other material does not enter thecover122 after extension of theelectrode126. It will be understood that providing thecover142 may not be necessary for appropriate operation of thelead120 with an implantable medical device.

With reference toFIGS. 1-3 and further reference toFIGS. 5 and 6, a selectedmap data194 of an anatomical region, such as aheart80 can be produced. Themap data194, as illustrated inFIG. 6, can be generated using only thePSU40. Thus, themap data194 can be considered imageless, which can refer to a map that is generated or displayed not using an external imaging device. A surface or virtual image, however, can be generated as discussed herein.

As discussed above, theheart80 includes an electrolyte, such as blood, which can be used to allow the sensing of a voltage with an electrode, such as theelectrodes108,110 of themapping catheter100 orelectrode126 of thelead120. The voltages sensed by theelectrodes108,110 are generated by the currents conducted through patches46a-50b, as particularly illustrated inFIGS. 1 and 2 and removed fromFIG. 5 for clarity. The patches positioned on the patient26 create virtual axes within thepatient26 of induced voltage gradients. A determination of a position of the electrode can be made by sensing the varying voltages within the patient while the current is conducted in thepatient26. Theelectrodes108,110 of themapping catheter100 can sense the voltage of each of the three axes to determine a three dimensional position of themapping electrodes108,110 within thepatient26. Similarly, the electrodes of theleads120,140 can be used to sense the voltages in the three axes to determine the position of the electrodes within thepatient26. Themapping catheter100, including theelectrodes108,110, can be moved through various portions in the patient26 while the electrodes sense the voltages, substantially continuously or as selected, among the three axes to determine multiple three dimensional positions of the electrodes.

A selected number of sensing measurements can be made, such as manual selection or automatic selection at selected time intervals. The sensed voltages can then be used to determine a relative position of the electrodes, as discussed herein. In addition, such as when the twoelectrodes108,110 are provided, a direction of thecatheter100 can also be determined. For example, a location of both of theelectrodes108 and110 can be made. Based upon this determination a determination of direction of thecatheter100 or orientation of the catheter can be made based upon the two location or position determinations. It will be understood, that a similar direction determination can be made regarding any appropriate catheter with at least two electrodes positioned along its length.

Thecatheter100 can be used by positioning it in avein144 of the patient26 through anincision146 made in the dermis of thepatient26 and an introducer or other appropriate mechanism can be used to introduce themapping catheter100 into thevein144. As discussed above, themapping catheter100 can include the Swan-Ganz catheter which can include a syringe orsimilar device150 to inject a fluid or gas to inflate theballoon102. A pressure meter orsensor152 can also be interconnected with the lead that is within theballoon102 to sense a pressure placed on theballoon102 when the balloon is within thepatient26. For example, once theballoon102 is inflated, such as when theballoon102 is positioned exterior to thesheath104, a pressure induced on theballoon102 will be transmitted through thecatheter106 and can be measured with thepressure meter152. It will be further understood, however, that a pressure meter or transducer can also be positioned at any appropriate location, such as within theballoon102. As discussed further herein, the measurement of a pressure pulse or a pressure change can be used to identify various regions of theheart80 by theuser22. In this regard, an increase or change in pulsatile pressure can be used to identify regions of the heart such as the right atrium, right ventricle, pulmonary artery, and the locations of valves.

With initial reference toFIG. 7, aprocedure180 is illustrated that can use theposition sensing unit40, its associated patches interconnected with the PSU I/O box42, themapping catheter100, and thelead120 to map and determine a position of thelead120 in thepatient26 without the need to employ an external imaging device. Theprocedure180, as briefly discussed here, can include creating a map of a portion of thepatient26 and positioning leads within a portion of thepatient26. It will be understood that although theprocedure180 is discussed relating to a cardiac procedure, other appropriate procedures can be performed by positioning themapping catheter100, current patches and reference electrodes in different portions of thepatient26. For example, a map can be made of other areas, such as gastrointestinal areas, pleural areas, or other areas of the anatomy of the patient26 including an electrolyte material. Accordingly, theprocedure180 can be modified in an appropriate manner to be used with an appropriate procedure.

Theprocedure180 can start instart block182. Theprocedure180 can then proceed to preparing and configuring the position sensing unit and a display device, as illustrated inFIG. 1. Preparing the PSU inblock184 can include various steps, such as labeling the patches for positioning on thepatient26, interconnecting the patches with the PSU I/O box42, theworkstation38 with the PSU I/O box42, and other appropriate steps.

After thePSU40 is prepared inblock184 and the patches46a-50bcan be positioned on the patient26 inblock186. In addition, thereference patches52aand52bcan be positioned on the patient26 as well inblock186. The patches46a-52bcan be positioned on the patient26 as illustrated inFIGS. 1 and 2. Positioning of the patches on thepatient26 allows for theposition sensing unit40 to generate potentials within thepatient26 that can be sensed with theelectrodes108,110 of the mapping catheter and electrodes of thelead120. The patches46-52 can be attached on a skin surface of thepatient26. This can allow for efficient generation of the micro-current in thepatient26.

Thedisplay device58 and its associated controller or processor can then be adjusted to illustrate or display a right anterior oblique (RAO) and a left anterior oblique (LAO) view inblock188 and as particularly illustrated inFIG. 6. The two oblique views can illustrate for theuser22 views of the data mapped of the patient26 that can be generally similar to fluoroscopic or x-ray images otherwise acquired of thepatient26. However, because no imaging device is necessary to form the images, the view of the patient26 or access to thepatient26 is not obstructed by theimaging device28. As illustrated inFIG. 6, a legend cube can be used to identify the view angles being represented. As discussed above, the use of themapping catheter100 and theposition sensing unit40 can eliminate or substantially reduce fluoroscopic imaging of thepatient26, while maintaining an appropriate level of location identification of various portions, such as thelead120 within thepatient26. It will be understood, however, that any appropriate viewing angles can be displayed on thedisplay device58, the oblique views are merely exemplary.

Themapping catheter100 can be prepared inblock190. For example, thecatheter106 can be marked relative to thesheath104 for illustrating the position of theballoon102 necessary to position theballoon102 and electrodes just free of thesheath104. This is generally a sterile procedure, and can be performed in an appropriate sterile manner.

Themapping catheter100 can then be inserted or introduced into the patient inblock192. It will be understood that themapping catheter100 can be introduced into the patient26 in any appropriate manner. Upon introduction into thepatient26, plotting of data points with themapping catheter100 can begin inblock192. The plotting of the data points can include illustrating data points on thedisplay device58, illustrated inFIGS. 1 and 6. The data points can be acquired substantially continuously or at a selected rate. The plotting of the data points can producemapping data194 that can be illustrated in any appropriate manner, such as a plurality ofpoints198 on thedisplay device58. The plurality of points illustrated on thedisplay device58 can be produced by moving themapping catheter100 through theheart80, the veins of thepatient26, and other appropriate portions or moving mechanisms.

For example, once theballoon102 has been inflated, drag is induced on theballoon102, due to the flow of blood in thepatient26. This can assist theballoon102 to move generally in the direction of the flow of blood in the patient and allow for ease of movement and guiding of theballoon catheter100 within thepatient26. For example, theballoon catheter100 can be introduced into thepatient26 and the flow of blood can direct theballoon catheter100, from the right ventricle through the right ventricular outflow tract and into the pulmonary artery.

As illustrated inFIG. 6, thedisplay device58 can display a plurality of points that are acquired as themapping catheter100 is moved through the various portions of thepatient26. The plurality of points as thecatheter100 is moved through the patient, which is generally over time, allows for the creation of a map of the portion of the patient26 through which themapping catheter100 is moved. As exemplary illustrated inFIG. 6, thedisplay device58 can illustrate the acquiredmapping data194 to illustrate appropriate portions of theheart80.

Themap data points198 illustrated on the display device can also be managed for ease and efficiency of theuser22. For example, a selected density ofdata points198 can be selected. Once a density threshold is reached a representative data point can be illustrated on thedisplay device58 rather than all acquired map data points that have been acquired with themapping catheter100. In other words, arepresentative data point198 may actually represent more than one acquired position map point allowing fewer than all acquired position data points to be illustrated, but all can be used for rendering a surface, as discussed further herein. This can allow themap data194 display to be selectively uncluttered with multiple overlapping mapdata point icons198.

Landmarks can be identified inblock193 for display on thedisplay device58. Landmarks identified inblock193 can be any appropriate landmark and can be illustrated such as with atoroid204 or a selected point, such as a point of a different color orshape206 in themapping data194. The landmarks identified inblock193 can be any appropriate anatomical feature used as a landmark for a procedure. For example, an anatomical feature or landmark can include an osteom or opening, a valve, wall, or apex of theheart80 or other portions of the patient26 being mapped with themapping catheter100. The landmarks or further locations can be further limited based upon a determination of only the possible subsequent locations of the electrodes of the mapping catheter or lead. For example, from within the pulmonary artery themapping catheter100 or lead120 can generally only move back into the right ventricle. Accordingly, the mapped points or the information regarding the same can be provided to theuser22 to limit the possible further or next positions.

The landmarks can include, as illustrated inFIG. 6, afirst toroid204arepresenting a junction of the inferior vena cava and the right atrium, asecond toroid204brepresenting a tricuspid valve, athird toroid204crepresenting a pulmonic valve, and a fourth toroid206drepresenting a junction of the superior vena cava and the right atrium. Other icons can also be used to represent landmarks, such as atriangle206 that can represent an apex.

As various portions of the data are being acquired, the perspective or position of the virtual camera on thedisplay device58 can be changed. For example, during initial plotting of the data an auto-follow position can be illustrated, as selected inblock195. The auto-follow position allows the primary electrode or the electrode being tracked or the mapping electrode to be at the center of the display device. The auto-follow position can move the virtual camera as illustrated on thedisplay device58 based upon speed of movement of the electrode being tracked or the location of the tracked or primary electrode relative to the position of the virtual camera. Thus, the view on thedisplay device58 can be based upon the position of the electrode relative to the virtual position of the camera.

The auto-follow feature can be to keep the tip of the primary electrode as the center of focus ondisplay device58. Rather than allowing the camera view to jump to wherever the electrode tip happens to be at a given point in time, the method works by smoothly transitioning to that point. The rate of the transition is dependent upon the current center of focus's distance from the desired center of focus (the electrode's tip location). The set of rules that define how the center of focus gets updated and can include moving the camera view at a speed proportional to distance to the tip or moving it immediately to the new desired position if the point of current focus is close enough to the new desired focus. These rules allow the transition to be rapid when necessary, while avoiding unnecessary and exaggerated movement when the camera is close to being centered.

At a various or selected point, the auto-follow position can be discontinued inblock196. When discontinued the view of themapping data194 can remain unchanged on thedisplay device58 as the electrode, such as theelectrode126 of thelead120, is moved through theheart80 and its relative position is displayed on thedisplay device58. The auto-follow feature, however, can be restarted to maintain the tracked position of the electrode near a center of thedisplay device58. Further landmarks can be identified inblock197 during or after any portion of the map data acquisition, such a after the tricuspid valve has been passed or observed.

At an appropriate time, such as when auser22 selects that an appropriate amount of data has been selected or illustrated, a rendering of one or more of apoint198 in themapping data194 can be produced inblock200. The rendering can include a 3D rendered surface using the data points198 in themapping data194. Themapping data194 can be rendered, as discussed further herein, to illustrate or form a surface on thepoints198 or relative to thepoints198. The rendered data can be used to illustrate themapping data194 for appropriate purposes.

Once an appropriate amount of data has been acquired and illustrated on thedisplay device58, a selected procedure can use themapping data194 acquired frompatient26. For example, various leads can be positioned within thepatient26, such as in a right ventricle or in a right atrium. Therefore, theprocedure180 can exemplary include configuring a RV lead inblock202. Configuring the RV lead inblock202 can include interconnecting the RV lead with the PSU I/O box42 for guiding the RV lead, such as thelead120, to a selected point in thepatient26 and configuring thePSU40 to illustrate and display the RV lead as it is introduced and navigated through the patient. For example, as illustrated inFIG. 6, agraphical representation120′ of thelead120 can be displayed relative to or superimposed on themapping data194. Illustrating a graphical representation of thelead120 can allow theuser22 to understand the position of thelead120 relative to the mapped data of thepatient26. The representation of thelead120′ can be displayed relative to the data points198. For example, the data points can represent a 3D volume; accordingly thelead representation120′ may be partly obscured by some of the data points198. The representation of themapping data194, however, can be rotated as selected by theuser22 to view themapping data194 and thelead representation120′ in any appropriate selected manner.

It will also be understood that the mapping catheter can be removed from thepatient26 prior to positioning thelead120 in thepatient26. Theprocedure180 can then proceed to placing and testing the RV lead in the patient26 inblock206. Placing and testing the RV lead can proceed according to generally known methods such as for placing leads for pacing or defibrillation IMDs. In addition, configuring a RA lead inblock208 and placing and testing a RA lead inblock210 can also follow. It will be understood, however, that any appropriate procedure can be performed and a cardiac procedure is merely exemplary. In addition, any appropriate type of lead or number of leads can be positioned within theheart80 of thepatient26 for a selected procedure.

At a selected point, such as after the leads are positioned and tested, an option image can be obtained by an external imaging device inblock211. The external imaging device can include thefluoroscope28 or other appropriate external imaging system. The minimal or single image acquired by the imaging device can substantially reduce exposure to x-rays or the requirement of equipment usage.

Theprocedure180 can then end or terminate inblock212. The ending of the procedure can include appropriate steps, such as programming an IMD positioned within the heart, as illustrated inFIG. 13 connecting implanted leads to the IMD, closing the incision, implanting the implantable medical device, or other appropriate steps. Programming the IMD can include wireless programmer, such as using the Medtronic 2090 or Carelink™ programmer, provided by Medtronic, Inc. of Minneapolis, Minn., USA.

With reference toFIGS. 1 and 2, the patches46a-50bthat are prepared inblock184 and placed in a patient inblock188 can be any appropriate patches, such as the patches and controller of the Local Lisa™ previously sold by Medtronic Inc. of Minneapolis, Minn., USA. As an example, the LocaLisa® device can be used to generate the current in thepatient26. ThePSU40 can also be that disclosed in U.S. Pat. Nos. 5,697,377 or 5,983,126 to Wittkampf, incorporated herein by reference. The patches can be positioned on thepatient26, such as orthogonally or generally nearly orthogonally to one another, to create three orthogonal or generally nearly orthogonal axes within thepatient26, and particularly intersecting within theheart80 or other organ of interest of thepatient26. The patches46-50 can be oriented based upon the organ or region of interest in the patient so that the original is at the region of interest. In addition, various instruments can be used, such as of different size or configuration, based upon the organ being explored or mapped.

The applied patches46,48, and50, can each be used to conduct a substantially unique current waveform through thepatient26. For example, each pair of the patches can be used to conduct current at a different frequency. Alternatively, the currents could be time division multiplexed. Thus, thePSU40 can be used to generate the unique currents in thepatient26. The currents generated in the patient26 produce voltages that can be sensed with the electrodes,108,110 of themapping catheter100 or thelead120, to be used to determine the electrode's relative position in thepatient26.

The reference electrodes52 positioned on the patient26 can be used to as a reference electrode for the electrodes being used to sense a voltage in thepatient26. Thereference electrode52athat is positioned over the xiphoid process can remain substantially fixed relative to the patient26 Reference electrodes positioned on the patient26 provide a reference for determination of voltages by theelectrodes108,110 of themapping catheter100 within thepatient26.

As discussed above, at least one of the reference electrodes, such as thefirst reference electrode52a, can be positioned substantially on or over the xiphoid process of thepatient26. Positioning thereference patch52asubstantially near the xiphoid process of the patient26 can allow for a substantially fixed location of thereference patch52arelative to the patient26 regardless of respiration movement, cardiac movement, or the like of thepatient26. Also, as discussed above, positioning thesecond reference electrode52bsubstantially directly across from thefirst reference electrode52a(such as on a horizontal plane, as discussed above) can provide a second reference that can be used to reference themapping data194 generated or produced relative to thepatient26. Also, by positioning thesecond reference patch52bat this location relative to thefirst reference patch52a, respiration can be monitored by measuring the relative voltage or impedance difference between the tworeference patches52a,52busing thePSU40.

The various patches can be affixed to the patient26 in any appropriate manner, such as via generally known semi-permanent or permanent adhesives. The patches46-50 are also generally electrically coupled to the skin of the patient26 to allow current to be conducted within thepatient26. For example, the patches46-50 can be directly attached to a skin surface of thepatient26. The patches46-50, however, can be removed once mapping or other procedures are completed.

Enabling plotting inblock192 allows for generation of the multiple data points for generation of themapping data194 of thepatient26 and mapping of selected regions of thepatient26, such as theheart80. The mapping of theheart80 of the patient26 can be achieved by moving themapping catheter100 through selected portions of theheart80 of thepatient26. It will be understood, as discussed above, that any appropriate region of the patient26 can be mapped. Moving themapping catheter100 through theheart80 of thepatient26 allows for generation of themapping data194 based upon a plurality of sensed voltages and calculated impedances at multiple locations within theheart80 by theelectrodes108,110 of themapping catheter100. As themapping catheter100 moves through theheart80 of thepatient26, as exemplary illustrated inFIG. 5, data points can be acquired at a set interval of time or when selected by theuser22. Theuser22 can use thefoot pedal64 to determine when a data point is to be acquired or for selecting where a landmark should be illustrated and identified. Nevertheless, the movement of themapping catheter100 through theheart80 allows for collection of data points based upon sensing a voltage and/or calculating a impedance at multiple locations in theheart80.

For example, as illustrated inFIG. 5, as themapping catheter100 moves through theheart80, it can be positioned at different locations within theheart80. For example, as it enters the right atrium chamber of the heart it can be positioned in a first selected location, as illustrated by thephantom mapping catheter100′. A data point can be determined for the mapping catheter when it is atposition100′. The mapping catheter can further be moved through theheart80 such as to a second or third location, as illustrated at100 or100″, and data points can be further acquired at these additional locations. Although three points are specifically mentioned here, it will be understood, that any appropriate number of data points may be collected to form themapping data194, as illustrated inFIG. 6. These data points can be illustrated on thedisplay device58 as the data points198. As also illustrated inFIG. 6, a plurality ofdata points198 can be generated or acquired as themapping catheter100 is moved relative to thepatient26. It will also be understood that any appropriate number ofdata points198 can be displayed on thedisplay device58.

The data points198 can be represented individually or as a group. For example, a selected sphere, circle, or other appropriate geometric shape can be used to represent one or moreacquired data points198 of a position of themapping catheter100, or itsrespective electrodes108,110, within thepatient26. A single sphere data icon illustrated on thedisplay device58 can be displayed when two, three, or more data points have been collected for a respective voxel of themapping data194. Therefore, a singledata point representation198 on thedisplay device58 can be representative of one or more position data points acquired with themapping catheter100. Accordingly, theimage display58 can be densely or sparsely populated with representations of the position data points of themapping catheter100. The representation can be based upon a selection of theuser22 or other appropriate selections.

In addition, themapping catheter100 can move through theheart80 according to various forces. For example, thesheath104 of themapping catheter100 can be a substantially deflectable or guidable sheath. Additionally, themapping catheter100 can be guidable according to generally known techniques or processes. Therefore, themapping catheter100 can be moved through the patient26 by direction of theuser22. In addition, forces within thepatient26, such as the flow of blood, can be used to move themapping catheter100 through theheart80.

Theballoon portion102 can generate drag within thepatient26 due to blood flow or other fluid flows within thepatient26. Therefore, as illustrated inFIG. 5, themapping catheter100 can enter theheart80 at a selected location and be moved through theheart80 via drag formed on theballoon portion102 to assist in moving theballoon portion102, and the associatedelectrodes108,110, through theheart80 such as to or through the pulmonary artery. Therefore, themapping catheter100 can move relative to the patient26 in any appropriate manner, including a drag generated on theballoon portion102.

With continuing reference toFIGS. 2,5, and7 and further reference toFIG. 8, thecatheter100 can be moved through theheart80. As thecatheter100 is moved through theheart80, the positionsensing unit system40 can determine or calculate positions of theelectrodes108,110 of themapping catheter100. Each of these determined locations can be displayed on thedisplay device58, as illustrated inFIG. 8, as various data points including198aand198b. Each of the data points collected regarding a position of themapping catheter100 can also include a time stamp or cycle stamp. Therefore, for example, a first data point198aand a second data point198bcan include different time stamps. The time stamps can indicate which was acquired first as themapping catheter100 moved relative to theheart80. As discussed above, drag on theballoon portion102 can cause movement of thecatheter100 through theheart80.

Accordingly, a movement direction can be determined and illustrated based upon the calculated or determined locations over time of themapping catheter100. An arrow199 can also be illustrated on thedisplay device58 to represent the movement direction. The arrow199 can provide an indication to auser22 of the movement direction in theheart80 and can assist in determining landmarks.

In addition, as themapping catheter100 is moved through theheart80, as illustrated inFIG. 8, pulsative pressure exerted on theballoon portion102 can be measured with thepressure meter152 to determine a pressure pulse exerted on theballoon portion102. The pressure pulse can be illustrated as a wave form that can be used to assist in identifying various locations in theheart80, or other locations in thepatient26. The measured waveform may be low fidelity due to compressible gases in thelumen106 of thecatheter100, but may be of enough fidelity to identify anatomical landmarks or portions. As the data points are collected regarding the location of themapping catheter100, in particular theelectrodes108,110, a pressure pulse related to these positions can also be determined. Theworkstation38 can save or associate each of the pressure pulses with the data points regarding the location of themapping catheter100 when the pressure pulse was measured. Accordingly, each of the data points198 of themapping data194 can include information collected with themapping catheter100. In addition, themapping catheter100 can be used for electrogram recording and display. For example, equal atrial and ventricular contributions to the endocardial electrogram could help confirm a location proximal to the valve. Therefore, each of the data points198 of themapping data194 can have information associated therewith other than a position of thecatheter100.

The additional information can be used in conjunction the position information to assist in identifying various regions of theheart80, such as landmarks. For example, different portions of the heart, such as valves, chambers and the like can be identified using the electrograms, pressure information, and the like. This information, which is associated with the data points198, can be used to identify landmarks in themapping data194 of theheart80. Accordingly, as illustrated inFIG. 6, the landmarks can be illustrated on thedisplay device58 to assist a physician in identifying or recalling selected regions of theheart80 determined with themapping catheter100. Thelandmarks204,206 can be identified using the physician's knowledge, information collected from themapping catheter100, and information collected from other instruments such as an electrocardiogram (ECG).

The landmarks can be labeled on thedisplay device58 in an appropriate manner. Landmarks displayed and labeled on thedisplay device58 can include alead line220 that interconnects thelandmark204 with atext box222. The length of thelead line220 and the position of thetext box222 can be calculated to ensure that the position of thetext box222 does not obscure or obscures as few as possible the data points198 displayed on thedisplay device58. In addition, the labeling of thelandmarks204,206 or the identification landmarks that should be labeled or identified can also be done with thefoot pedal64 and/or thejoystick62. For example, depressing thefoot pedal64 can be used to show a menu of possible landmarks and the joystick can be used to highlight the landmarks and thefoot pedal64 can select a landmark label. Theworkstation38 can then illustrate the landmark on thedisplay device58 and further provide thetext box label222 and thelead line220 in an appropriate manner.

Returning reference toFIGS. 6 and 7, identification of landmarks inblock202 can be illustrated on thedisplay device58 as briefly discussed above. Selected landmarks, such as valves, veins or vessels, can be illustrated using thetoroid204. Thetoroid landmark204 includes a radius centered on anaxis204′. Theaxis204′ and a radius of thetoroid204 can be based upon the data points198 acquired near thetoroid204 or the location of the landmark which thetoroid204 identifies. For example, a selected portion of the data points198 near thetoroid204, such as one or two or any appropriate millimeters on either side of thetoroid204 can be used to determine the direction of thecentral axis204′ for display on thedisplay device58. In addition, the data points198 within thetoroid204 can be used to determine the radius of thetoroid204 for display on thedisplay device58. Therefore, thelandmark toroid204 can, in addition to identifying a selected landmark, also provide additional information to theuser22 regarding the size of the particular area, such as an area of a valve or vessel, and a relative orientation of the valve or vessel to the other acquired data.

The data points198 of themapping data194 can also include the time stamps, such as discussed above. The time stamps can further be used to identify those data points acquired in a recent period, such as the data points198′, which can be illustrated as darker or a different color than older acquireddata points198″. The illustration of a decay or timing of the illustration of the data points can be used by theuser22 to identify a most current location of themapping catheter100, thelead120, or any other appropriate reason.

As discussed in theprocess180 inFIG. 7, rendering of a surface can occur inblock200. Rendering the surface can proceed based upon techniques, as exemplary described herein, to render a surface relative to or with the data points198 of the acquireddata194. Rendering the surface can occur using at least two surface rendering techniques.

A first surface rendering technique forblock200 can include a “swept surfaces”. The swept surfaces rendering technique can include a swept surface process240 illustrated inFIG. 9 that can render the sweptsurfaces image data241 illustrated inFIG. 10. The swept surfaces process240 can begin in a start block242. As discussed in relation toFIG. 7, themapping catheter100 can be prepared and introduced in the patient26 as apart of the start block242.

The swept surfaces process240 can include selecting a sphere size in block244. The sphere size selected in block244 can be any appropriate size, such as a relative diameter of the electrode, such as theelectrode108 or110. According to the swept surfaces process240, the size of the electrode can be determined or estimated to be a sphere. Therefore, the sphere size in block244 can substantially be the physical size of theelectrodes108,110 of themapping catheter100. For example, the sphere or radius size can be about 1 mm to about 50 mm, including about 1 mm to about 15 mm, or about 1 or 5 mm to about 15 mm.

Once a sphere size is determined in block244, themapping catheter100 can be moved in the patient in block246. As the mapping catheter is moved in the patient in block246, the data points198 regarding the position of thecatheter100 can be acquired in block248 and illustrated as the data points198, illustrated inFIG. 10. As eachposition data point198 is acquired, a sphere based on the sphere size input in block244 can be determined. The plurality of spheres can be used to form the swept surface rendering241 in block250. The display of the surfaces of a plurality of spheres generates or renders three dimensional data regarding each of the position data points acquired regarding the position of the mapping catheter in block248. The rendering, however, can be limited by the size of the sphere selected in block244, but can be performed in substantially real time.

Because three dimensional data is displayed on thedisplay device58, an appropriate three dimensional surface can be displayed using the three dimensional data displayed in block250. Moreover, the surface can be illustrated in real time allowing a real time acquisition and growth of the 3D surface. Accordingly, a three dimensional sweptsurface241 representing a passage of themapping catheter100 can be displayed on adisplay device58 rather than simpleindividual points198.

The swept surfaces process240 can then end in block252. The rendered surface inblock200 using the swept surfaces process240 inFIG. 9 can create a substantially real time surface model using themapping catheter100. In addition, as illustrated inFIG. 10, thedisplay device58 can display both of theindividual points198 of the mapping data and the swept surfaces rendering241 of the mapping data for viewing by theuser22.

Again, returning reference toFIG. 7, and additional reference toFIG. 11, rendering the surfaces inblock200 of theprocedure180 can also or alternatively occur with a second process including isometric or other appropriatesurface extraction procedure280. Using the data points198 acquired and displayed on the display device58 asurface rendering281, illustrated inFIG. 12, can be produced with thesurface extraction procedure280.

Thesurface extraction procedure280 can begin instart block282, which can include preparing and positioning themapping catheter100 within thepatient26. The data points for rendering according to thesurface extraction procedure280 can be acquired as discussed above, plotted relative to thepatient26, and saved in a memory that can be accessed by theworkstation38 or any appropriate processor. Accordingly, the plotted points can be inputted into thesurface extraction procedure280 atblock284. Once selected plotted points have been inputted, thesurface extraction process280 can proceed to point discretization inblock286. Point discretization can include appropriate hierarchies or organizational methods, including known cube grid or octree arrangements.

If a cube grid organization method is chosen, each of the points from the plotted points inblock284 can be assigned to a cube of a selected size in a grid pattern. Each of the cubes could be assigned the data points that fall within the perimeter of the cube of the grid when the position data points198 are overlaid or aligned with the cube grid. The cube grid could then be queried to identify those points that exist within a selected cube. In this way, theposition point data198 can be identified and further processed or rendered, as discussed further herein.

According to various embodiments, an octree procedure can also be used. The octree structure is a data organization structure that includes a hierarchal or trunk structure with nodes or leaf nodes where data points exist. Accordingly, a leaf node does not exist on the hierarchical structure unless a data point exists at the particular location. Accordingly, position data points198 would exist on the trunk structure where they were determined. Thus, there is no memory wasted for empty cubes, as may exist if no data happen to be acquired for a particular cube or grid location.

According to various embodiments, point discretization inblock286 allows for an indexing or layout of the data for access and further processing steps in thesurface extraction process280. Accordingly, the point discretization can include appropriate discretization or indexing processes including those discussed above. Point discretization is used to determine an appropriate location of the data acquired and for querying in further processing, discussed below.

After point discretization inblock286, a Gaussian Voxelization can occur inblock288. The Gaussian Voxelization inblock288 is used to voxelize the data into 3D data along a selected grid, such as in x, y and z directions. The voxelization of the data can include the formation of a three dimensional voxel data set along the grid pattern.

The voxelization can proceed by visiting each cube or voxel in the grid and identifying the distance of a data point that is a selected distance from a center of the voxel by querying the point discretization data. This can include finding all data points that are within a selected radius from a center of each of the voxels. If a data point is found for a particular voxel, a scalar value is computed based upon the point's distance from the center of the voxel. A Gaussian function can be used to determine the discretization value given to the point where the value decreases in the known Gaussian manner as the point deviates or is further from the center of the voxel. Accordingly, a data point closer to the center of the voxel is given a higher value than a point that is further from the center of the voxel. Each voxel is then given or assigned the highest scalar value for the points within that voxel. A voxel with no data points can be assigned a zero, while a voxel with more than one data point is assigned the highest value based upon each of the points within that particular voxel.

Once the data has been voxelized inblock288, an Isometric (Iso) surface extraction can occur inblock290. The Gaussian Voxelization inblock288 creates a substantially three dimensional volume set from which a surface can be extracted inblock290. Appropriate surface extraction algorithms can be used to extract the surface based upon the Gaussian Voxelization inblock288. For example, a marching cubes algorithm can be used to extract a surface based upon the Gaussian Voxelization data inblock288. The marching cubes algorithm can be implemented from various sources such as the visualization tool kit at http://public.kitware.com/vtk, incorporated herein by reference. Various other techniques are also described in U.S. Pat. No. 4,710,876 to Cline and Lorensen, incorporated herein by reference. Other appropriate extraction techniques can also include marching tetrahedrons. Regardless, the surface extraction algorithm can use the voxelized data inblock288 to determine a surface.

Once the surface extraction is completed inblock290, the extracted data can be saved as a geometric mesh inblock292. The geometric data can include triangle data relating to the marching squares extraction that occurs inblock290. The saved geometric mesh data inblock292 can then be rendered on thedisplay device58 inblock294. An appropriate rendering system can be used, such as the OpenGL® rendering subroutine or system. The rendering of the data to thedisplay device58 inblock294 can display the extracted threedimensional surface281 of the data acquired with themapping catheter100.

The extracted threedimensional surface281 that can be viewed by theuser22 to assist in identifying locations within the anatomy, such as within theheart80, or for understanding the anatomy of theheart80 or positions of themapping catheter100 or lead120 within theheart80. It will be understood, thatlandmark icons204 can also be displayed relative to the extracted threedimensional surface281, As illustrated inFIG. 12. In other words, landmarks that are identified in the position data points198 can be super-imposed on the extracted threedimensional surface281 as well. It will be further understood, that landmarks can be illustrated on any appropriate data, such as the sweptsurfaces data241 as well. Thesurface extraction process280 can then end inblock296. Accordingly, thesurface extraction process280 can be used to render or display a surface of the data points198 acquired with themapping catheter100.

The data points198 acquired with themapping catheter100 can also be displayed unrendered or unfiltered on thedisplay device58. That is, as illustrated inFIG. 7, the mapping data can be displayed on thedisplay device58 as the multiple points determined with the mapping catheter as a part of the positionsensing unit system40. Thus, a plurality of data points can be displayed on the display device for viewing by theuser22.

In addition, themapping data194 displayed on thedisplay device58 can be displayed with or without any selected filtering. For example, the data points being displayed on thedisplay device58 can be displayed in substantially real time as they are acquired and calculated. That is, as the voltage is sensed and the impedance calculated, the determined location of themapping catheter100 or thelead120 can be displayed on thedisplay device58.

Theposition sensing unit40 can also filter the data displayed on thescreen58. The data displayed on thescreen58 can be a smoothed or average location. For example, a point displayed on the screen can include an average location of the data points acquired and determined for themapping catheter100 or thelead120 for a set period of time. For example, an average location of themapping catheter100 or thelead120 for five seconds can be displayed on thedisplay device58. It will be understood, however, that a selected amount of filtering may or may not be used to display the data points on thedisplay device58. It may be selected, such as when positioning thelead electrode126 into theheart80, a substantially unfiltered view be given to theuser22 to allow for a substantially precise illustration of a position of thelead electrode126 relative to the data points or surface displayed on thedisplay device58. This can assist in a substantially precise location and implantation of thelead electrode126 during a selected procedure.

As discussed above, thePSU40 can be used to implant any appropriate system, for example an implantable medical device (IMD)300 can be implanted. TheIMD300 and its associated lead or leads120 can be implanted without theexternal imaging device28. Although, it will be understood, that theimaging device28, or appropriate imaging device, can be used during an implantation procedure, such as to confirm placement of thelead120 once positioned with thePSU40. It will also be understood, that thePSU40 can be used to supplement placement of an implantable member, such as thelead120, with theimaging device28, to reduce the number of images acquired, or eliminate direct imaging of thepatient26 and instruments entirely.

TheIMD300, illustrated inFIG. 13, can include implantable pacemakers, implantable cardioverter defibrillator (ICD) devices, cardiac resynchronization therapy defibrillator devices, or combinations thereof, is exemplarily illustrated. An exemplary dual chamber IMD can include the Concerto Model C154DWK, sold by Medtronic, Inc. of Minneapolis, Minn., USA, but appropriate single chamber IMDs can also be implanted. TheIMD300 can include an implantable case orbody assembly302. Theimplantable case302 can be formed of appropriate materials and include appropriate features, such as a hermetically sealed body wall. The body wall can be made of a substantially inert material or of a conducting material.

Thelead assembly120 can be interconnected with theimplantable case302 at a selected time. As discussed above, the lead can be guided to an implant location, such as in a right ventricle, with thePSU40. Thelead120 can then have itselectrode126 fixed to theheart80. It will be understood, however, that any appropriate number of leads can be interconnected with theimplantable case302 and can include any appropriate number of electrodes.

With continued reference toFIG. 13, a programmer orprogramming system310 can be provided. Theprogrammer310 can include a telemetry system that is operable to wirelessly transmit a signal to the processor within thecase body302. It will be understood that a wired communication system can also be used. In addition, an induction system can be used where a coil is positioned near thecase body302 and a signal is sent from the programmer via induction. Theprogrammer310 can also receive information from the IMD300 (e.g. tachycardia rhythms and times and programming settings) to assist in providing an appropriate program for pacing. Theprogrammer310 can include any appropriate programming system, including one generally known to those skilled in the art, such as the Medtronic 2090 or Carelink™ programmer, sold by Medtronic, Inc. of Minneapolis, Minn., USA.

Further areas of applicability of the present teachings will become apparent from the detailed description provided above. It should be understood that the detailed description and specific examples, while indicating various embodiments, are intended for purposes of illustration only and are not intended to limit the scope of the teachings.

Claims (36)

What is claimed is:

1. A method of illustrating mapping data from a patient, comprising:

generating a variable parameter between a first drive patch and a second drive patch in contact with the patient;

sensing a first parameter at a first map position and a second parameter at a second map position in the patient;

acquiring map data points based upon the sensed parameters;

saving the acquired map points;

displaying on a display device the saved map points;

identifying an anatomical feature that is at least a location in the patient based at least in part on the saved map points; and

inputting an identification of the anatomical feature and displaying a representing the anatomical feature on the display device with the map points.

2. The method ofclaim 1, further comprising:

viewing the displayed map points by a user;

determining a landmark by the user based on viewing the displayed map points;

selecting from a menu a landmark identification;

inputting a position of the landmark relative to the displayed map points based upon the identified anatomical feature; and

wherein the anatomical feature is the landmark and the icon is displayed relative to a map displayed on the display device of the saved map points.

3. The method ofclaim 1, further comprising:

selecting a number of the saved map points;

determining a spatial relationship of the saved map points; and

displaying on the display device a representative icon of more than one of the saved map points.

4. The method ofclaim 3, further comprising:

executing instructions with a processor such that the display device displays a representative icon of saved map points where the representative icon does not overlap a second representative icon on the display device.

5. The method ofclaim 2, further comprising:

acquiring data related to the map point including at least one of measuring a pressure pulse at a map point, an electrogram at a map point, a pressure change between at least two map points, a determination of all possible locations of a subsequent map point based upon a previous map point; or combinations thereof; and

determining a landmark based upon the acquired data for the map point.

6. The method ofclaim 5, wherein selecting a landmark identification includes selecting at least one of a valve, a heart chamber, a heart wall, an osteom or opening, or combinations thereof.

7. The method ofclaim 2, further comprising:

displaying a landmark icon representing the landmark at the inputted position of the landmark relative to the displayed map points; and

selecting the landmark icon from at least one of a point, a toroid, or combinations thereof.

8. The method ofclaim 2, further comprising:

displaying a text box on the display device identifying the landmark, wherein displaying the text box includes positioning the text box so as to minimally obstruct displayed map points on the display device; and

drawing a line between the text box and the landmark.

9. A method of illustrating mapping data from a patient, comprising:

generating a variable parameter between a first drive patch and a second drive patch in contact with a patient;

sensing a first parameter at a first map position and a second parameter at a second map position in the patient;

acquiring map data points based upon the sensed parameters;

saving the acquired map points;

displaying on a display device the saved map points; and

identifying an anatomical feature based at least in part on the saved map points;

viewing the displayed map points by a user;

selecting from a menu a landmark identification;

inputting a position of the landmark relative to the displayed map points based upon the identified anatomical feature;

displaying a toroid relative to the displayed map points at the inputted position of the landmark; and

determining an axis of the toroid based upon at least a map data point on either side of the toroid and defining an axis between the two saved map points.

10. The method ofclaim 9, further comprising:

selecting a plurality of saved map points on either side of the toroid and determining a best fit line between all of the saved map points to define the axis of the toroid.

11. A method of illustrating mapping data from a patient, comprising:

generating a variable parameter between a first drive patch and a second drive patch in contact with a patient;

sensing a first parameter at a first map position and a second parameter at a second map position in the patient;

acquiring map data points based upon the sensed parameters;

acquiring anatomical data associated with each map data point;

saving the acquired map points and the acquired anatomical data;

displaying on a display device the saved map points to represent at least a portion of the patient; and

identifying an anatomical feature of the patient that is at least one of a location or structure based at least on the saved map points and the saved anatomical data;

inputting a position of a landmark relative to the displayed map points based upon the identified anatomical feature; and

displaying a landmark icon representing a boundary of the landmark at the input position of the landmark and relative to the displayed map points on the display device.

12. The method ofclaim 11, further comprising:

selecting a number of the saved map points;

determining a spatial relationship of the saved map points;

displaying on the display device a representative icon of more than one of the saved map points; and

executing instructions with a processor such that the display device displays a representative icon of saved map points where the representative icon does not overlap a second representative icon on the display device.

13. The method ofclaim 11, further comprising:

viewing the displayed map points by a user;

wherein identifying the landmark includes selecting from a menu the landmark identification.

14. The method ofclaim 11, further comprising:

associating a time stamp with each acquired map point to associate an acquisition time of the acquired map point;

where an earlier time stamped map point includes a different display characteristic than a later time stamped map point.

15. The method ofclaim 11, wherein acquiring anatomical data further includes acquiring anatomical data related to the map point including at least one of measuring a pressure pulse at a map point, an electrogram at a map point, a pressure change between at least two map points, a determination of all possible locations of a subsequent map point based upon a previous map point, or combinations thereof.

16. The method ofclaim 15, further comprising:

viewing the displayed map points by a user;

selecting from a menu a landmark identification; and

wherein inputting the position of the landmark relative to the displayed map points is based upon an identified anatomical feature based on both the saved map points and the acquired anatomical data.

17. The method ofclaim 16, wherein selecting a landmark includes selecting at least one of a valve, a heart chamber, a heart wall, an osteom or opening, or combinations thereof.

18. The method ofclaim 17, further comprising:

displaying a text box on the display device identifying the landmark, wherein displaying the text box includes positioning the text box so as to minimally obstruct displayed map points on the display device; and

drawing a line between the text box and the landmark.

19. A method of illustrating mapping data from a patient, comprising:

generating a variable parameter between a first drive patch and a second drive patch in contact with a patient;

sensing a first parameter at a first map position and a second parameter at a second map position in the patient;

acquiring map data points based upon the sensed parameters;

acquiring anatomical data associated with each map data point;

saving the acquired map points and the acquired anatomical data;

displaying on a display device the saved map points; and

identifying an anatomical feature based at least in part on the saved map points and the saved anatomical data;

viewing the displayed map points by a user;

selecting from a menu a landmark identification;

inputting a position of the landmark relative to the displayed map points based upon the identified anatomical feature;

displaying a landmark icon representing the landmark at the inputted position of the landmark relative to the displayed map points;

wherein displaying the landmark icon includes displaying a toroid relative to the displayed map points at the inputted position of the landmark; and

determining an axis of the toroid based upon at least a map data point on either side of the toroid and defining an axis between the two saved map points.

20. The method ofclaim 19, further comprising:

selecting a plurality of saved map points on either side of the toroid and determining a best fit line between all of the saved map points to define the axis of the toroid.

21. The method ofclaim 19, further comprising:

determining a radius of the toroid for display on the display device based upon the saved map points in the toroid.

22. A method of illustrating mapping data from a patient, comprising:

generating a variable parameter between a first drive patch and a second drive patch in contact with a patient;

sensing a first parameter at a first map position and a second parameter at a second mapped position in the patient;

determining map data points based upon the sensed parameters;

sensing anatomical data associated with each map data point;

saving the acquired map points and the acquired anatomical data;

displaying on a display device the saved map points to represent at least a portion of the patient to identify a location of a structure of the patient, based at least in part on the saved map points and the saved anatomical data.

23. The method ofclaim 22, wherein sensing anatomical data further includes acquiring anatomical data related to the map point including at least one of measuring a pressure pulse at a map point, an electrogram at a map point, a pressure change between at least two map points, a determination of all possible locations of a subsequent map point based upon a previous map point, or combinations thereof.

24. The method ofclaim 22, further comprising:

rendering a surface based on the saved map data points,

wherein displaying on the display device the saved map points includes displaying the rendered surface of at least a portion of the patient and the identified anatomical feature is at least one of a location or structure of the patient displayed relative to the rendered surface.

25. The method ofclaim 22, further comprising:

displaying a boundary defining landmark icon representing a landmark at an inputted position of the identified location of the structure relative to the displayed map points.

26. The method ofclaim 25, further comprising:

displaying a text box on the display device identifying the landmark, wherein displaying the text box includes positioning the text box so as to minimally obstruct displayed map points on the display device; and

drawing a line between the text box and the landmark.

27. The method ofclaim 25, wherein displaying the boundary defining landmark icon relative to the displayed map points at the inputted position of the landmark includes displaying the boundary defining landmark icon around at least a portion of the rendered surface.

28. The method ofclaim 27, further comprising:

determining an axis through the boundary defining landmark icon; and

displaying an axis icon representing the determined axis.

29. The method ofclaim 28, further comprising:

forming the boundary of the landmark icon as a closed boundary.

30. A method of illustrating mapping data from a patient, comprising:

positioning a first drive patch and a second drive patch in contact with a patient to generate a voltage between the first drive patch and the second drive patch;

moving an instrument through an area of the patient between the first drive patch and the second drive patch to sense a first voltage at a first position and a second voltage at a second position in the patient, where a plurality of map points are acquired and saved based upon the sensed voltages;

viewing on a display device the saved plurality of map points; and

visually identifying an anatomical feature as at least a structure of the patient based at least on the displayed plurality of map points.

31. The method ofclaim 30, further comprising:

selecting from a menu a landmark identification; and

inputting a position of the identified structure relative to the displayed map points.

32. The method ofclaim 31, further comprising:

determining a landmark based upon an acquired anatomical data relating to each map point including at least one of measuring a pressure pulse at each map point, electrogram at each map point, a pressure change between at least two map points, a determination of all possible locations of a subsequent map point based upon a previous map point, or combinations thereof.

33. The method ofclaim 31, wherein the identified structure is at least one of a valve, a heart chamber, a heart wall, an osteom or opening, or combinations thereof.

34. The method ofclaim 33, further comprising:

selecting a landmark icon from at least one of a point, a toroid, or combinations thereof to display relative to the displayed plurality of map points to represent the identified structure.

35. The method ofclaim 33, wherein visually identifying the anatomical feature includes identifying a passage between a first portion and a second portion of the patient; and

further includes selecting and displaying a landmark icon to illustrate the identified passage and a center through the passage.

36. A method of illustrating mapping data from a patient, comprising:

positioning a first drive patch and a second drive patch in contact with a patient to generate a voltage between the first drive patch and the second drive patch;

moving an instrument through an area of the patient between the first drive patch and the second drive patch to sense a first voltage at a first position and a second voltage at a second position in the patient, where map data points are acquired and saved based upon the sensed voltages;

viewing on a display device the saved map points;

visually identifying an anatomical feature based at least in part on the displayed map points;

selecting from a menu a landmark identification, wherein selecting a landmark includes selecting at least one of a valve, a heart chamber, a heart wall, an osteom or opening, or combinations thereof;

inputting a position of the landmark relative to the displayed map points based on the identified anatomical feature;

selecting a landmark icon from at least one of a point, a toroid, or combinations thereof to display the landmark icon representing the landmark at the inputted position of the landmark relative to the displayed map points; and

selecting a plurality of saved map points on either side of the toroid and determining a best fit line between all of the saved map points to define the axis of the toroid.

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